PURPOSE: Much attention has been paid to the augmentation of data from randomized controlled trials (RCTs) with real world evidence (RWE) in oncology; however, cardiovascular disease (CVD) also presents an interesting case. This workshop demonstrates the importance of a process for all evidence suppliers and users, including manufacturers, professional societies, and HTA organizations, to be undertaking. Panelists show how their organizations use RWE to augment data from RCTs to evaluate the clinical, cost-effectiveness, and patient-reported outcomes of CVD therapies and make recommendations on furtherance of a more meaningful effort in the future. Additionally, the chair will facilitate a series of debate questions with audience participation, culminating with a vote on the strongest answer to each question DESCRIPTION: Presenter 1 (cardiologist) will present the rationale for continuous RWE review of CVD: 1) high prevalence of CVD conditions; 2) significant burden on patients and society; and 3) put RCT data in the context of RWE. He will describe the role that professional associations can play in the update process – informing providers, patients, and HTA bodies. Presenter 2 (manufacturer) will outline strength and challenges of RWE, and show how the RWE-informed update process is carried out in CVD research and development within his company. Presenter 3 (HTA representative) will describe the appropriate use of RWE and feasibility of HTAs in performing systematic CVD therapeutics updates and discuss means that could be used, including particulars on structure, process, and use of results. Session Chair (consultant) will act as organizer of workshop participants, posing questions to the presenters to illustrate different points of view and facilitating the audience participation period. She will also add an American perspective to points the European presenters make for additional workshop depth.